AMIGO: Image-Guided Gynecologic Brachytherapy

• Sponsor: Dana-Farber Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01399658
• Collaborator: (none)
• Enrollment: 93
• Location: 1
• Arm: 1
• Duration (Months): 57
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

Standard therapy for gynecologic cancers involves the use of brachytherapy, also called internal radiation therapy or implant radiation. The treatment being studied consists of standard brachytherapy with the additional use of MRI to guide the insertion of radioactive applicators. The purpose of the study is to find out whether MRI-guided brachytherapy is practical and beneficial when compared to the standard CT-guided brachytherapy placement. The investigators are hoping that this MRI procedure will decrease the risk of giving too high a radiation dose to the bladder or bowel.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer; Uterine Cancer; Vaginal Cancer; Carcinoma of the Vulva	Procedure: Image-guided brachytherapy; Drug: 3'-Deoxy-3'-18f-Fluorothymidine	Phase 2

Detailed Description

The insertion of the brachytherapy applicator will be administered in the Advanced Multimodality Image-Guided Operating (AMIGO) suite at Brigham and Women's Hospital. Subjects will undergo an MRI scan in the AMIGO suite ensuring proper placement of the applicator. Subjects may have an optional FMISO-PET scan.

Subjects will have a follow-up visit including physical exam, pap smear, and MRI of the pelvis and/or PET scan 90 days after treatment.

Subjects will have a follow-up visit including physical exam, pap smear, and MRI of the pelvis and/or PET scan 180 days after treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Clinical Trial to Evaluate Image-Guided Gynecologic Brachytherapy in the Advanced Multimodality Image-Guided Operating Suite (AMIGO)
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Image-Guided Brachytherapy Image-guided brachytherapy	Procedure: Image-guided brachytherapy; MRI-guided application of brachytherapy; Drug: 3'-Deoxy-3'-18f-Fluorothymidine; Assessing tumor proliferation in Gynecologic cancer

Outcome Measures

Primary Outcome Measures

1. Mean Doses Givem [Measured while on treatment, up to 2 months.]

   Doses given to the tumor, rectum, and sigmoid obtained after AMIGO-guided placement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically or cytologically confirmed carcinoma of the cervix (Stage I-IVA), carcinoma of the uterus (Stage IIIB), carcinoma of the vagina (Stage I-IVA), or carcinoma of the vulva (stage I-IVA)

• Life expectancy > 6 months

• MRI of the pelvis and/or PET-CT within 4 months prior to entering study

Exclusion Criteria:

• Uncontrolled intercurrent illness

• Pacemaker, brain aneurysm clip, inner ear implant, neurostimulator, or metal fragments in the eye

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Dana-Farber Cancer Institute

Investigators

• Principal Investigator: Martin King, MD, PhD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Martin King, Prinicipal Investigator, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT01399658
• Other Study ID Numbers: 11-098
• First Posted: Jul 22, 2011
• Last Update Posted: Mar 2, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Martin King, Prinicipal Investigator, Dana-Farber Cancer Institute: Brachytherapy; Gynecological cancer
• Additional relevant MeSH terms: Vaginal Neoplasms; Uterine Neoplasms; Vulvar Neoplasms

Study Results

Participant Flow

Recruitment Details	September 2011 to February 2016

Arm/Group Title	Image-Guided Brachytherapy
Arm/Group Description	Image-guided brachytherapy Image-guided brachytherapy: MRI-guided application of brachytherapy 3'-Deoxy-3'-18f-Fluorothymidine: Assessing tumor proliferation in Gynecologic cancer
Period Title: Overall Study
STARTED	93
COMPLETED	87
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Image-Guided Brachytherapy
Arm/Group Description	Image-guided brachytherapy Image-guided brachytherapy: MRI-guided application of brachytherapy 3'-Deoxy-3'-18f-Fluorothymidine: Assessing tumor proliferation in Gynecologic cancer
Overall Participants	93
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	60
Sex: Female, Male (Count of Participants)
Female	93 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 3.2%
Not Hispanic or Latino	65 69.9%
Unknown or Not Reported	25 26.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 3.2%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	5 5.4%
White	64 68.8%
More than one race	1 1.1%
Unknown or Not Reported	20 21.5%

Outcome Measures

1. Primary Outcome

Title	Mean Doses Givem
Description	Doses given to the tumor, rectum, and sigmoid obtained after AMIGO-guided placement.
Time Frame	Measured while on treatment, up to 2 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Image-Guided Brachytherapy
Arm/Group Description	Image-guided brachytherapy Image-guided brachytherapy: MRI-guided application of brachytherapy 3'-Deoxy-3'-18f-Fluorothymidine: Assessing tumor proliferation in Gynecologic cancer
Measure Participants	84
Tumor	93.9 (8.59)
Rectum	63.2 (9.04)
Sigmoid	58.63 (12.05)

Adverse Events

Time Frame	From registration to 90 days post-procedure, up to 15 months.
Adverse Event Reporting Description	Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Arm/Group Title	Image-Guided Brachytherapy
Arm/Group Description	Image-guided brachytherapy Image-guided brachytherapy: MRI-guided application of brachytherapy 3'-Deoxy-3'-18f-Fluorothymidine: Assessing tumor proliferation in Gynecologic cancer
All Cause Mortality
	Image-Guided Brachytherapy
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Image-Guided Brachytherapy
	Affected / at Risk (%)	# Events
Total	0/93 (0%)
Other (Not Including Serious) Adverse Events
	Image-Guided Brachytherapy
	Affected / at Risk (%)	# Events
Total	86/93 (92.5%)
Blood and lymphatic system disorders
Anemia	71/93 (76.3%)
Cardiac disorders
Cardiac arrest	1/93 (1.1%)
Palpitations	1/93 (1.1%)
Ear and labyrinth disorders
External ear inflammation	1/93 (1.1%)
Hearing impaired	6/93 (6.5%)
Tinnitus	1/93 (1.1%)
Eye disorders
Blurred vision	1/93 (1.1%)
Gastrointestinal disorders
Abdominal pain	21/93 (22.6%)
Anal hemorrhage	1/93 (1.1%)
Colitis	1/93 (1.1%)
Constipation	28/93 (30.1%)
Diarrhea	50/93 (53.8%)
Duodenal hemorrhage	2/93 (2.2%)
Dyspepsia	3/93 (3.2%)
Fecal incontinence	1/93 (1.1%)
Flatulence	2/93 (2.2%)
Gastrointestinal pain	1/93 (1.1%)
Hemorrhoids	10/93 (10.8%)
Nausea	34/93 (36.6%)
Proctitis	10/93 (10.8%)
Rectal hemorrhage	6/93 (6.5%)
Rectal pain	3/93 (3.2%)
Stomach pain	1/93 (1.1%)
Vomiting	18/93 (19.4%)
General disorders
Chills	3/93 (3.2%)
Edema limbs	4/93 (4.3%)
Fatigue	56/93 (60.2%)
Fever	5/93 (5.4%)
Localized edema	1/93 (1.1%)
Pain	3/93 (3.2%)
Infections and infestations
Enterocolitis infectious	2/93 (2.2%)
Sepsis	2/93 (2.2%)
Skin infection	1/93 (1.1%)
Urinary tract infection	7/93 (7.5%)
Vaginal infection	1/93 (1.1%)
Injury, poisoning and procedural complications
Dermatitis radiation	30/93 (32.3%)
Fracture	1/93 (1.1%)
Seroma	1/93 (1.1%)
Spinal fracture	1/93 (1.1%)
Investigations
Activated partial thrombop	1/93 (1.1%)
Alanine aminotransferase i	1/93 (1.1%)
Alkaline phosphatase incre	3/93 (3.2%)
Aspartate aminotransferase	2/93 (2.2%)
Blood bilirubin increased	1/93 (1.1%)
Creatinine increased	9/93 (9.7%)
INR increased	1/93 (1.1%)
Lymphocyte count decreased	61/93 (65.6%)
Neutrophil count decreased	27/93 (29%)
Platelet count decreased	34/93 (36.6%)
Weight gain	1/93 (1.1%)
Weight loss	9/93 (9.7%)
White blood cell decreased	55/93 (59.1%)
Metabolism and nutrition disorders
Acidosis	2/93 (2.2%)
Alkalosis	1/93 (1.1%)
Anorexia	14/93 (15.1%)
Dehydration	1/93 (1.1%)
Hypercalcemia	2/93 (2.2%)
Hyperglycemia	56/93 (60.2%)
Hyperkalemia	2/93 (2.2%)
Hypermagnesemia	3/93 (3.2%)
Hypoalbuminemia	10/93 (10.8%)
Hypocalcemia	42/93 (45.2%)
Hypoglycemia	1/93 (1.1%)
Hypokalemia	24/93 (25.8%)
Hypomagnesemia	28/93 (30.1%)
Hyponatremia	28/93 (30.1%)
Hypophosphatemia	3/93 (3.2%)
Musculoskeletal and connective tissue disorders
Arthralgia	3/93 (3.2%)
Back pain	10/93 (10.8%)
Bone pain	2/93 (2.2%)
Buttock pain	1/93 (1.1%)
Flank pain	3/93 (3.2%)
Generalized muscle weaknes	1/93 (1.1%)
Muscle weakness lower limb	1/93 (1.1%)
Myalgia	8/93 (8.6%)
Myositis	1/93 (1.1%)
Pain in extremity	1/93 (1.1%)
Pelvic soft tissue necrosi	1/93 (1.1%)
Superficial soft tissue fi	1/93 (1.1%)
Nervous system disorders
Cognitive disturbance	1/93 (1.1%)
Dizziness	4/93 (4.3%)
Headache	12/93 (12.9%)
Memory impairment	1/93 (1.1%)
Paresthesia	3/93 (3.2%)
Peripheral sensory neuropa	4/93 (4.3%)
Psychiatric disorders
Anxiety	14/93 (15.1%)
Confusion	2/93 (2.2%)
Depression	7/93 (7.5%)
Insomnia	10/93 (10.8%)
Renal and urinary disorders
Acute kidney injury	5/93 (5.4%)
Chronic kidney disease	2/93 (2.2%)
Cystitis noninfective	9/93 (9.7%)
Hematuria	18/93 (19.4%)
Proteinuria	9/93 (9.7%)
Urinary fistula	3/93 (3.2%)
Urinary frequency	37/93 (39.8%)
Urinary incontinence	10/93 (10.8%)
Urinary retention	5/93 (5.4%)
Urinary tract obstruction	2/93 (2.2%)
Urinary tract pain	25/93 (26.9%)
Urinary urgency	3/93 (3.2%)
Urine discoloration	1/93 (1.1%)
Reproductive system and breast disorders
Dyspareunia	2/93 (2.2%)
Pelvic pain	16/93 (17.2%)
Perineal pain	1/93 (1.1%)
Vaginal discharge	40/93 (43%)
Vaginal dryness	18/93 (19.4%)
Vaginal fistula	1/93 (1.1%)
Vaginal hemorrhage	16/93 (17.2%)
Vaginal pain	6/93 (6.5%)
Vaginal stricture	3/93 (3.2%)
Respiratory, thoracic and mediastinal disorders
Cough	4/93 (4.3%)
Dyspnea	5/93 (5.4%)
Wheezing	1/93 (1.1%)
Skin and subcutaneous tissue disorders
Alopecia	1/93 (1.1%)
Bullous dermatitis	1/93 (1.1%)
Pruritus	2/93 (2.2%)
Skin ulceration	1/93 (1.1%)
Telangiectasia	1/93 (1.1%)
Vascular disorders
Hot flashes	8/93 (8.6%)
Hypotension	3/93 (3.2%)
Thromboembolic event	2/93 (2.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.